Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

WITH MS DRUG STATUS IN LIMBO, FIRMS WORK ON PATIENT CONFIDENCE

It was barely two hours after a panel recommended to the Food and Drug Administration that it allow the drug Tysabri back on the market when Dr. Joseph Berger got an e-mail inviting him to a special class.The
Star-Telegram